COMPUTER SYSTEM VALIDATION ENGINEER HF

Descripción de la oferta

Entreprise:
Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 countries and supports more than 750 clients worldwide throughout their project's lifecycle. Our expertise covers five areas of innovation: Business and Management, Information Technologies, Engineering and High Technologies, Telecommunications and Biotech and Pharma. With more than 65 offices across the world, the Group offers proximity support to its clients in all their locations and many opportunities of international careers for employees.
In 2018, Amaris aims to reach a turnover of 260 million euros, 5000 employees and to develop its workforces with the anticipation of a further 2000 new job openings. We expect to triple our workforce within the next few years and reach a leading international position in independent consulting.
Poste et missions:
Would a new challenge in the Lifesciences be interesting for your career goals?
To intensify Amaris' growth in the pharmaceutical industry, we are looking for computer system validation (CSV) engineers who will:
Establish methodological and documentary validation references
Validation of CSV throughout the whole project cycle (validation plan, risk analysis, IQ, OQ, PQ)
Undertake Corrective Action / Preventive Action regarding CSV aspects
Set up tests protocols
Guide our client regarding regulatory compliance and computer validation.
Profil:
You hold at least a Master`s degree in engineering or pharmacy
You hold three to ten years of experience in computer system validation
You are familiar with the processes and legal requirements for pharmaceutical industry (cGMP’s, 21CFR part11, GAMP).
You are fluent in English.
You are proactive, have good communication skills, and are capable of working in a multidisciplinary team towards a common goal.